CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions

NCT ID: NCT03214835

Last Updated: 2020-07-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2019-12-31

Brief Summary

The study will take place at Rambam medical center, department of Otolaryngology Head and Neck Surgery, for two years. Patients suspected of LPR or laryngeal l tumor and are candidate for laryngeal or hypopharyngeal biopsies will be recruited.

Detailed Description

First- all patients visiting our clinic with laryngeal complaints suspicious for either LPR or laryngeal tumor will fill the RSI questionnaire. Then fiberoptic examination will be performed by a laryngologist that will complete the RFS score.

Patients with suspicious lesions will be referred for TFL standard biopsy and CDx brush biopsy in order to determine whether the lesions are malignant or benign. The pathologic diagnosis of invasive carcinoma from a TFL biopsy is considered equivalent to the pathology results from a direct laryngoscopy biopsy. All patients with benign pathology or carcinoma in-situ (CIS) on TFL biopsy will be referred for subsequent direct laryngoscopy (DL) for definitive diagnosis. At the time of the DL biopsy will include also another CDx brush smear. Patients with benign-appearing lesions will be taken for lesion removal and biopsy.Before removal of the lesion a CDx brush smear will be collected.

All the participants suspected of LPR will have: PHmetry with Manometry andCDx brush biopsy.All relevant demographic and clinical data will be retrieved for analysis.

CDx biopsies will be an addition to the routine management of the patients in the diagnosis and follow-up of laryngeal lesions and LPR and will not replace the standard regimen.

Conditions

Laryngeal Disease; Laryngeal Tumor; Laryngopharyngeal Reflux

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Brush biopsy for laryngeal lesion

Brush biopsy of the larynx - in addition to the standard biopsy

Group Type: EXPERIMENTAL

Endo CDx Brush biopsy

Intervention Type: DEVICE

In patients with laryngeal lesion the brush biopsy will be taken with the standard cup biopsy - either in the clinic or in the OR. In LPR patients brush biopsy will be taken in the clinic.

Brush biopsy for LPR

Brush biopsy of the larynx at the post cricoid region - in addition to the standard examination for LPR (PH monitoring double probe)

Group Type: EXPERIMENTAL

Endo CDx Brush biopsy

Intervention Type: DEVICE

In patients with laryngeal lesion the brush biopsy will be taken with the standard cup biopsy - either in the clinic or in the OR. In LPR patients brush biopsy will be taken in the clinic.

Interventions

Endo CDx Brush biopsy

In patients with laryngeal lesion the brush biopsy will be taken with the standard cup biopsy - either in the clinic or in the OR. In LPR patients brush biopsy will be taken in the clinic.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age 18 or over
• patients suspected to suffer from LPR
• Patients with laryngeal/hypopharyngeal lesions.

Exclusion Criteria

• Patient refusal
• Patients with anatomical variants which precludes biopsy taking.
• Patients with allergy to lidocain-based local anesthesia agents.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: collaborator

CDx Diagnostics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacob Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Other Identifiers

CDx Laryngeal and LPR Study

Identifier Type: -

Identifier Source: org_study_id